BASEL, Switzerland, Feb. 24, 2004 (PRIMEZONE) -- Basilea Pharmaceutica AG today announced the successful completion of phase I development for BAL8557, a novel water-soluble azole suitable for both oral and intravenous administration. BAL8557 is active against a broad range of fungal pathogens, including strains resistant to current antifungal treatments. Based on successful phase I results, Basilea is currently preparing a phase II development program.
The phase I program demonstrated that BAL8557 was rapidly converted to the active drug moiety following oral or intravenous administration. In single ascending dose studies, subjects were given 100, 200, or 400 mg of BAL8557 orally, or 50, 100, or 200 mg intravenously. The PK profile showed good oral absorption with low to moderate inter-subject variability, and nearly dose-proportional exposure. These pharmacokinetic properties were confirmed in multiple ascending dose studies, with 50 and 100 mg daily oral maintenance doses during 3 weeks. In all of these studies, no significant adverse events were noted and plasma concentrations of active drug reached levels that exceeded the values observed to cure systemic fungal infections in preclinical animal models.
"We are very pleased with the results of our phase I program," said Basilea CEO Anthony Man MD. "Systemic fungal infections represent a significant clinical problem in hospitals worldwide. Predictable pharmacokinetics is a key factor in developing more effective, safer and more convenient drugs. BAL8557 behaved as anticipated in both oral and intravenous once-daily dosing regimens. The broad antifungal spectrum and favourable biopharmaceutical properties, combined with the predictable PK and good safety profile observed in the phase I studies could make BAL8557 a preferred treatment for serious and life threatening fungal infections. Our intention is to make BAL8557 available to patients and the medical community as soon as possible."
The press release can be downloaded from the following link: http://hugin.info/134390/R/935614/129305.pdf
About Basilea
Basilea Pharmaceutica AG is an emerging biopharmaceutical company headquartered in Basel, Switzerland actively engaged in the discovery and development of innovative drugs for the treatment of bacterial infections, fungal infections and skin diseases associated with high unmet medical needs. Basilea was founded in October 2000 with significant resources to support the discovery, development and marketing of innovative medicines.
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